PHARMA BUSINESS ANALYST - CONNECTED REGULATORY INTELLIGENCE

Pharma Business Analyst - Connected Regulatory Intelligence The IQVIA Connected Regulatory Intelligence (CRI) is a groundbreaking innovative solution that simplifies, integrates, and automates end-to-end regulatory processes that are essential for industry clients in meeting their global quality, regulatory and safety compliance obligations.
The CRI solution leverages IQVIA's unique regulatory intelligence platform to allow users to seamlessly query IQVIA's intelligence as well as their own organization's insights and Health Authority Interactions (HAI) to improve and accelerate quality, regulatory and safety activities such as strategic planning, submission management and publishing work amongst others.
Position Purpose This role is a member of the product team and will be responsible for the analysis of the Pharma regulatory affairs business processes and systems The individual will write business requirements and will translate those into documentation that can be used by the software development teams The role will work on several regulatory software applications that leverage the Connected Regulatory Intelligence Platform The individual fulfilling this role will also help the definition of additional intelligence required in the platform to further drive regulatory process automation This role will involve actively interacting with customers to discuss regulatory processes, user experience and software implementation to gather and document customer feedback Principle Accountabilities.
To Accomplish this role, the candidate will apply their experience of Pharma regulatory activities and the knowledge of current regulations and standards across the globe to.
Define the regulatory business requirements for the software applications Translate the business requirements into technical documentation Create high-level solution concept diagrams that detail how to solve the problem Facilitate brainstorming, visual collaboration and diagramming sessions between all the stakeholders, business experts and engineering teams Successfully complete technical documentation and support the development and QC activities across the development lifecycle Continuously monitor and update new, revised, or emerging global regulatory requirements as required by the business.
Experience and Skills Required.
Qualifications in engineering, life sciences or related discipline In-depth understanding of global and country specific regulatory requirements Possesses at least 5 years of relevant regulatory affairs experience and\/or technical expertise preferably in preparing application dossiers and agency interactions Experience of gathering and maintaining regulatory intelligence will be an advantage Knowledge and experience using software systems developed for regulatory, safety, clinical and quality (validated systems) will be an advantage Ability to become the liaison between the business and the technical development teams Demonstrated ability to manage and drive project contributions in a timely manner Ability to create strong working relationships across the organization.
collaborating with cross-functional teams including technology, regulatory, quality, clinical affairs, and others Self-motivated and enthusiastic Strong analytical and problem-solving skills The opportunity.
You will be working on a groundbreaking innovative solution.
We are a diverse, global team that shares a passion for collaboration and solving problems using best functional expertise and most advanced technologies to transform how regulatory teams do their daily jobs.
Together, we will make a difference.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.
We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.
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